Dental appliance

ABSTRACT

The present invention is a dental oral appliance to open the airway for a sleeping individual who suffers with snoring or obstructive sleep apnea. The appliance includes a base to secure the appliance within the mouth for the individual. Typically, the base will fit over and secure to the lower teeth of the individual. The appliance also includes a tongue restraining device connected to the base. The tongue restraining device has a substantial breach formed therein to permit movement of the tongue so that the user can more easily swallow saliva. A ramp might also be attached to the anterior portion of the base to advance the mandible.

CROSS-REFERENCE TO RELATED APPLICATIONS

The applicant hereby claims benefit of U.S. Provisional PatentApplication No. 61/009,693 (filed Dec. 31, 2007). The specification ofsaid provisional patent application is incorporated herein by thisreference as though set forth in full.

The applicant hereby claims benefit of U.S. Provisional PatentApplication No. 61/123,849 (filed Apr. 11, 2008). The specification ofsaid provisional patent application is incorporated herein by thisreference as though set forth in full.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not Applicable

FIELD OF INVENTION

The present invention relates to dental appliances for the treatment ofsnoring.

BACKGROUND OF THE INVENTION

Medical studies have shown that snoring can have serious medicalconsequences for people. Many people who snore suffer from ObstructiveSleep Apnea. If not diagnosed or if left untreated, Obstructive SleepApnea can result in severe medical consequences such as systemic highblood pressure, cardiovascular disease, stroke and heart attack.

Spouses also suffer through the night from the noise of the snorer.Snoring not only disturbs the sleeping pattern of the snorer, it is alsodisruptive to his or her spouse. This leaves both unrefreshed, tired andsleepy throughout the day. It can cause sleepiness while driving,reading, working or doing other tasks.

A broad variety of intra-oral and dental appliances and devices are nowavailable to treat a patient for snoring. However, most of these areuncomfortable to the user and studies have shown that the vast majorityof these devices go unused. Other treatments for snoring include varioussurgeries, which are drastic steps that can have significant adverseconsequences to the patient and often do not work in any event.

The present invention is a dental oral appliance for use with patientswho suffer with sleep disorders, to reduce or eliminate snoring and toopen the airway for a sleeping individual who suffers with obstructivesleep apnea.

SUMMARY OF THE INVENTION

The present invention is a dental oral appliance, for use with patientswho suffer with sleep disorders, to reduce or eliminate snoring and toopen the airway for a sleeping individual who suffers with obstructivesleep apnea. The appliance also opens the airway in an awake individual,whose tongue partially blocks/obstructs the airway thereby increasingthe airflow in and out and allows more relaxed fuller breathing. This isaccomplished as the tongue is trained by the patient wearing theappliance at night to re-position itself forward and up. The appliancetypically covers the lower teeth and has an open center where the tonguesits. In the preferred embodiment, the portion of the appliance thatcovers the lower teeth is custom fit for the specific patient. It ispreferred that the appliance fits snuggly on the lower teeth to securethe appliance within the mouth.

There is a transverse strip that extends from the lower right molars tothe lower left molars that pushes the tongue upward and forward, therebybreach the airway. In the preferred embodiment, the strip issubstantially U-shaped thereby forming a substantial breach therein. Itis further preferred that the strip comprises a downward slope. Thebreach allows the tongue some freedom of movement so that the user canmore easily swallow saliva.

The present invention can be modified with a ramp on the front so that,when the user closes his or her mouth, the upper front teeth hit it andare forced forward creating mandibular advancement in a single archappliance. This additionally aids in further alleviating snoring.Another function of the ramp is as a discluding element to free themuscles of mastication during sleep. This is extremely helpful whentreating patients that have temporomandibular joint (TMJ) dysfunctionand Myofascial Pain Dysfunction (MPD). These patients' symptoms can beworsened by treatment with traditional Mandibular Advancement Appliancesbut, because of the ramp functioning as a discluding device, they can bemore easily and successfully treated.

The dental appliance can comprise a single piece of material. However,it is possible to have the mouth piece (the portion engaging the lowerteeth) and the tongue restraining device be separate pieces. The reasonfor this design is that the size of everyone's mouth and tongue isdifferent. Therefore the position of the “U” in terms ofanterior-posterior, as well as angulation in a vertical plane, needs tohave the ability to move to fit each person. By having the “U” as aseparate member, it can be attached with a ratchet-type hinge forvertical angulation as well as a sliding-slot mechanism for theanterior-posterior adjustment. Other connection methods known to thoseof skill in the art can be used as well.

Over time, as the tongue is trained to stay in position during sleep,the device can be adjusted in increase forward positioning of thetongue. After the tongue is fully trained to stay in position, somepatients will no longer need to wear the device on a daily basis toavoid snoring.

For a patient who does not have lower molars or who is missing too manylower teeth to secure the device adequately, the dental appliance can bedesigned for the upper teeth, incorporating aspects of the presentinvention such as the anterior ramp and an adjustable strip to restrainand reposition the tongue forward.

BRIEF DESCRIPTION OF THE DRAWINGS

The above and other objects and advantages of the present invention willbe apparent upon consideration of the following detailed description,taken in conjunction with the accompanying drawings, in which referencecharacters refer to like parts throughout, and in which:

FIG. 1 illustrates an exemplary securing means.

FIG. 2 shows the securing means with a front ramp formed thereon.

FIG. 3 is a dental appliance according to the present invention.

FIG. 4 shows an abstract version of the dental appliance viewed fromabove.

FIG. 5 shows a top view of an abstract version of a dental applianceaccording to the present invention with a W-shaped tongue restrainingdevice.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 illustrates an exemplary securing means 1 or base. The securingmeans shown is acrylic that is molded to fit securely over the lowerteeth of the patient. Materials other than acrylic can be used as areknown to those with skill in the art. Other types of bases can beutilized in the invention. For example, the base might secure to theupper teeth only or both the upper and the lower teeth. The base shownin FIG. 1 has a right end 7 and a left end 8. For the particular patientfor whom the base was molded, the right end 7 is located at theposterior side of the last molar on the right and the left end 8 islocated at the posterior side of the last molar on the left. It ispreferred that the base is specially molded to fit snuggly over thelower teeth of the patient so that the appliance is better secured whenin the mouth.

FIG. 2 shows the base of FIG. 1, except that a front ramp 2 has beenformed on the front of the securing means 1. In the embodiment shown,the front ramp 2 is also formed of acrylic, although other materials canbe used. It is also possible to form the base 1 and front ramp 2simultaneously as a single piece of material, including plastic, acrylicor otherwise. The front ramp 2 extends forward from the anterior portionof the base at an upward angle. When the dental appliance is insertedinto position within the mouth, the front ramp forces the lower jawforward providing mandibular advancement. This helps to alleviatesnoring and sleep apnea. In the preferred embodiment, from the bottom ofthe front of the base, the bottom of the front ramp rises at about a 45degree angle. It is preferred that that angle is between 40 and 60degrees. From the top of the front of the base, the top of the frontramp rises at about a 30 degree angle. It is preferred that that angleis between 25 and 45 degrees. For comfort, it is preferred that the rampis tapered and that is rounded without sharp edges. If the base issecured to the upper teeth, the ramp will need to be angled differently.

FIG. 3 shows an exemplary dental appliance according to the presentinvention. The dental appliance includes the base 1 and the front ramp2. Extending from the ends of the base 1 is a tongue restraining device3. When the dental appliance is positioned in the patient's mouth, thetongue restraining device keeps the tongue from falling back, therebykeeping it from blocking the airway. It also will then be moved forwardduring future visits, bringing the tongue with it to a more forward andupper position. This keeps the airway open and prevents/reduces thenumber of apneic events (the number of times the tongue falls back andblocks the airway for at least 10 seconds). The tongue restrainingdevice, by positioning the tongue anteriorly/forward and superiorly/up,significantly opens the airway.

In the preferred embodiment, the tongue restraining device issubstantially U-shaped and comprises a downward slope. Because thetongue restraining device is U-shaped, a substantial breach is formedtherein between the points where the tongue restraining device connectsto the base. In FIG. 3, there is an imaginary dashed line 5 illustratingthe boundary of the opening 6 formed by the breach within the tonguerestraining device. The imaginary dashed line 5 extends from one end ofthe “U” to the other. More specifically, the opening 6 is formed by theanterior surface 9 of the tongue restraining device. The purpose of theopening 6 is to allow movement of the tongue within the opening 6 sothat it is easier for the patient to swallow saliva.

It is possible for the base 1 and tongue restraining device 3 to beformed simultaneously from a single piece of material (e.g. acrylic orother plastic). It is possible to form the base 1 and the tonguerestraining device 3 from a material (such as an acrylic) that can bereheated and remolded. This allows the medical practitioner to readjustthe tongue restraining device 3 for patient comfort or otherwise.Materials that are commonly used to make moldable mouth guards can beused for this purpose.

It is also possible for the base 1 and the tongue restraining device 3to be formed separately and later connected together. In one embodiment,the base 1 and the tongue restraining device 3 are connected by anadjustable connection means such as a ratchet mechanism that allows theposition of the tongue restraining device 3 to be adjusted. It ispreferred that the adjustable connection means allows the tonguerestraining device 3 to be lengthened and/or raised/lowered pivotallywith respect to the base 1. By having the “U” as a separate member, itcan be attached with a ratchet-type hinge for vertical angulation aswell as a sliding-slot mechanism for the anterior-posterior adjustment.

Various types of adjustment means known to those skilled in the art canbe utilized to allow length and/or pivotal adjustment of the tonguerestraining device. Examples of such adjustment means are described inthe following US patents: U.S. Pat. No. 7,415,912 (adjustable components(300 and 400 shown on in the figure on the front page) can be lengthenedand shortened with locking screws in slots); U.S. Pat. No. 7,399,288(adjusting rod to lengthen and shorten neck brace); U.S. Pat. No.7,384,406 (adjustable-length strut); U.S. Pat. No. 7,377,779 (means toadjust posts); U.S. Pat. No. 7,320,672 (means to adjust angularextension); U.S. Pat. No. 7,166,132 (means to pivotally adjust boneprosthesis); U.S. Pat. No. 7,156,654 (means to lengthen orthodonticappliance); U.S. Pat. No. 7,037,287 (adjustable pivot mechanism for kneebrace (see FIG. 6)); U.S. Pat. No. 6,964,566 (adjustment means forlengthening dental oral appliance (see FIG. 9)); U.S. Pat. No. 6,960,175(adjustment means for pivot in leg brace (see FIGS. 2 and 3)); U.S. Pat.No. 6,926,363 (mechanism for adjusting angle of hinge); U.S. Pat. No.6,796,951 (mechanism for pivotal adjustment (see FIG. 6)); U.S. Pat. No.6,783,361 (length in dental appliance adjusted by jack screw controlledby a ratchet); U.S. Pat. No. 6,739,277 (length adjustment mechanism (seeFIG. 2)); U.S. Pat. No. 6,656,144 (mechanism for pivotal joint); U.S.Pat. No. 6,629,841 (pivot adjustment mechanism (see FIG. 5)); U.S. Pat.No. 6,523,492 (length adjustment mechanism); U.S. Pat. No. 6,413,232(pivot adjustment member (see FIGS. 4 and 5); and U.S. Pat. No.6,383,156 (range of motion hinge with an adjustable length strut (seeFIGS. 2A through 8). The complete specification of each patent listed inthe previous sentence is incorporated herein by this reference as thoughset forth in full.

In the preferred practice, the tongue restraining device will belengthened and pivoted downward as the tongue is trained to stay in goodposition. This can be accomplished in a number of ways, as discussedabove. For example, a plurality of appliances can be manufactured at onetime for the patient (typically, three to seven). The base will be thesame for each appliance (specially molded according to the lower teethof the patient). However, the tongue restraining devices will getprogressively longer with a more downward slope. The first appliancewill have a relatively short tongue restraining device that slopesslightly downward from the base connection points. After the patient hasgotten use to the new appliance and the tongue is partially trained, thepractitioner can then give the patient the second appliance. The tonguerestraining device on the second appliance will be somewhat longer andwill have a more downward slope from the base connection points. Thisprocess will continue until the tongue restraining device keeps thetongue in a completely correct posture.

The same type process can be accomplished by fabricating new appliancesas they are needed. Also, an adjustable appliance, as described above,can be used for this purpose. The number of adjustments required willvary depending on the patient's ability to tolerate the appliance andthe changes. Typically, the number of adjustments will be from three toseven. However, 10 or more adjustments might be required.

It should be noted that a dental appliance according to the presentinvention can also comprise a base and a front ramp but not a tonguerestraining device. It is also possible for a dental appliance accordingto the present invention to comprise a base and a tongue restrainingdevice but not a front ramp.

FIG. 4 provides an abstract version of the dental appliance viewed fromabove (top view). The abstract version includes the base 1, the frontramp 2, the tongue restraining device 3, and the opening 6 within thetongue restraining device. The purpose of FIG. 4 is to permit discussionof the possible dimensions of the appliance's components. In the exampleshown in FIG. 4, the length of the imaginary dashed line 5 is about 4centimeters. Imaginary dashed line 10 is the width of base 1 near theleft end. This is about 14 millimeters. This length is due directly tothe width of the last left molar of the patient.

Imaginary dashed line 11 is the width of the tongue restraining deviceproximate to the base. Various sizes are possible. For example, thelength of imaginary dashed line 11 might be 15 millimeters or it mightbe 8 millimeters. This width depends on what room is needed for thetongue to move within the opening 6 and the need for the stability ofthe tongue restraining device.

Imaginary dashed line 12 is the width of the tongue restraining deviceat the center. The length of imaginary dashed line 12 can also varyaccording to what is required to accommodate movement of the tonguewithin the opening 6 and for patient comfort. Typically, the length ofimaginary dashed line 11 will be greater than the length of imaginarydashed line 12. The length of imaginary dashed line 12 might besomething like 4 or 5 millimeters.

Imaginary dashed line 13 is the length that the front ramp 2 juts outfrom the base 1. This might be something like 7 or 8 millimeters.

There is no exact way to determine the optimal length of a tonguerestraining device. In fabricating an appliance for a new patient, onemight measure from the back of the lower teeth to the location where thetongue begins to go downward in the throat. That measurement can be usedas the length of the tongue restraining device. As the treatmentprogresses, the tongue restraining device can be lengthened and thedownward slope increased. The greater the downward slope the greater thelength can be.

As can be seen in FIG. 4, from a top view, the size of the breach in thetongue restraining device will generally be substantial. Typically,viewed from above, the area of the breach will be greater than theapparent area of the tongue restraining device. In fact, viewed fromabove, the area of the breach might be more than twice as large as theapparent area of the tongue restraining device. It is preferred that thesize of the breach is as large as is possible, while still maintainingthe structural integrity of the tongue restraining device and thedesired positioning of the tongue.

It should be noted that shapes other than a U-shape are possible for thetongue restraining device. A rounded W-shape might be used, forinstance. In such a configuration, the anterior surface forms an openingwithin the tongue restraining device to allow for movement of the tonguefor swallowing but provides an accordion effect that allows the tonguerestraining device to be more easily remolded so as to allow the tonguerestraining device to be wider or narrower. FIG. 5 shows provides a topview of an abstract version of such a configuration, with a front ramp15, a base 16 and a tongue restraining device 17.

1. A dental oral appliance to open the airway for a sleeping individualwho suffers with snoring or obstructive sleep apnea comprising: a basecomprising means to secure the appliance within the mouth for theindividual; and a tongue restraining device connected to the base,wherein said tongue restraining device comprises an anterior surfacethat forms a substantial opening within said tongue restraining deviceto permit movement of the tongue.
 2. The appliance of claim 1 in whichthe tongue restraining device is substantially U-shaped.
 3. Theappliance of claim 1 in which the base is configured to secure to thelower teeth.
 4. The appliance of claim 1 in which the base and tonguerestraining device are formed from a single piece of material.
 5. Theappliance of claim 4 in which said material comprises plastic.
 6. Theappliance of claim 4 in which said material comprises acrylic.
 7. Theappliance of claim 4 wherein the tongue restraining device can be heatedand repositioned.
 8. The appliance of claim 1 wherein the tonguerestraining device, when secured in the mouth, comprises a downwardslope relative to the user's teeth.
 9. The appliance of claim 1 whereinthe base and the tongue restraining device comprise separate pieces. 10.The appliance of claim 9 wherein the tongue restraining device isconnected to the base by adjustable connection means.
 11. The applianceof claim 1 wherein, wherein the tongue restraining device has a top sideand, when the tongue restraining device is viewed from the top, theopening formed by the anterior surface is greater in area than thesurface of the tongue restraining device.
 12. The appliance of claim 1further comprising a ramp projecting from the base that is configured,when the appliance is secured in the mouth, to force the mandibleforward.
 13. The appliance of claim 1 wherein the base is custom fit forthe individual.
 14. The appliance of claim 1 wherein the tonguerestraining device is custom fit for the individual.
 15. A dental oralappliance to open the airway for a sleeping individual who suffers withsnoring or obstructive sleep apnea comprising: A base comprising meansto secure the appliance within the individual's mouth; and a rampextending from the base that is configured such that, when the applianceis secured within the mouth, the ramp forces the mandible forward. 16.The appliance of claim 15 wherein the ramp, relative to the teeth, isangulated upward.
 17. The appliance of claim 15 wherein the base iscustom fit for the individual.
 18. A dental oral appliance to open theairway for a sleeping individual who suffers with snoring or obstructivesleep apnea comprising: A base comprising means to secure the appliancewithin the individual's mouth; a tongue restraining device; andconnecting means to connect said tongue restraining device to said basewherein said connecting means permits adjustment of the position of thetongue restraining device relative to the base.
 19. The appliance ofclaim 18 wherein the base is custom fit for the individual.
 20. Theappliance of claim 18 wherein the base is configured to secure to thelower teeth.